Staying Ready for FDA Inspections (When They're Less Predictable)

Описание: The FDA Group’s Nick Capman speaks with Jeff Brenneman, Vice President of Global Operations Quality at Alora Pharmaceuticals. With more than 25 years of pharmaceutical manufacturing experience spanning branded, generic, and OTC products, Jeff brings a deep perspective on sustaining inspection readiness across multiple sites while leading global quality teams.

Jeff shares why inspections feel less predictable today—with more variability in inspector experience and a higher likelihood that minor issues become formal observations—and how leaders can respond without overreacting. He explains how to prepare documentation so that it’s understandable to any inspector, what makes a quality system truly “robust” in practice, and why culture, accountability, and simplicity matter as much as compliance.

Nick and Jeff also explore practical steps for keeping data integrity controls sharp, building efficient systems that don’t overburden teams, and fostering engagement so quality is seen as a partner, not just a policing function.

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